The candidate was shown to be more than 90 percent effective in preventing COVID-19 infection.
Things are looking good for Pfizer’s COVID-19 coronavirus vaccine candidate.
According to a news release, Pfizer and BioNTech’s mRNA-based vaccine candidate, BNT162b2, was found in the first interim efficacy analysis to be more than 90 percent effective in preventing infections in patients without evidence of prior COVID-19 infection. That analysis evaluated 94 confirmed cases in trial participants.
The high efficacy rate came seven days after the second dose of the vaccine candidate meaning that it provides protection 28 days after the initiation of the two-dose schedule. There have not been any serious safety concerns but the study will continue to collect additional safety and efficacy data which will be discussed with regulators worldwide, the release says.
The companies are looking to submit for an emergency use authorization from the U.S. food and Drug Administration (FDA) soon after the required safety milestone is achieved. That is expected to be in the third week of November, according to the release.
“Today is a great day for science and humanity,” Alberta Bourla, Chairman and CEO of Pfizer, says in the release. “The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19. We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen. With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis. We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks.”
In July, the U.S. Department of Health and Human Services (HHS) placed an initial order for 100 million doses of the vaccine candidate from Pfizer and BioNTech for $1.95 billion after it is manufactured and either obtains approval or emergency use authorization from the FDA. The federal government will also be able to acquire up to an additional 500 million doses and American patients will receive the vaccine free, according to the release.